Intravenous anesthetics
Conditions
Interventions
Sponsors
The Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) male and female subjects aged 18-75 years (including the cutoff value); 2) Body mass index (BMI) in the range of 18-30 kg/m2 (including the cut-off value) and body weight =100 kg; 3) American Society of Anesthesiologists (ASA) grade I-III; 4) patients undergoing one of the routine gastroscopy or colonoscopy procedures with an expected digestive endoscopy procedure time of less than 20 minutes; 5) Subjects who voluntarily participated and signed informed consent after fully understanding the purpose, content, process and possible risks of the trial; 6) Able to communicate well with the investigators, willing and able to abide by the lifestyle restrictions specified in the protocol, and cooperate to complete the trial process.
Exclusion criteria
Exclusion criteria: 1) patients who require complex digestive endoscopic techniques (such as cholangiopancreatography, endoscopic ultrasonography, endoscopic mucosal resection, endoscopic submucosal dissection, peroral endoscopic myotomy, etc.), or who plan to undergo tracheal intubation or laryngeal mask insertion; 2) patients who may have gastrointestinal obstruction, gastrointestinal retention, active gastrointestinal bleeding, or regurgitation and aspiration; 3) The subject's medical history and past history are judged by the investigator to have diseases or dysfunctions that may affect the clinical trial, including but not limited to chronic or serious diseases of the cardiovascular system, respiratory system, digestive system, urinary system, endocrine system, blood system, and lymphatic system; Or the presence of conditions that may significantly affect drug distribution, metabolism and excretion, history of surgery, medical history related to the effect of the test drug and any other special circumstances; 4) Patients with central nervous system diseases (Parkinson's disease, Alzheimer's disease, essential tremor, hepatolenticular degeneration, Huntington's disease, epilepsy, etc.), mental system diseases (schizophrenia, mania, anxiety disorder, bipolar disorder, psychosis, etc.), and long-term use of psychotropic drugs (continuous use for 30 days or more, intermittent use for 3 months or more) Patients with cognitive dysfunction, craniocerebral injury, possible intracranial hypertension, cerebral aneurysm, and cerebrovascular accident history; 5) Those who are known to be allergic to etomidate, opioids, propofol, naloxone or other narcotic drugs and their similar drug components, soy, peanut, egg or egg products, or who have allergic constitution (allergic to two or more drugs, environment or food), or who are prone to rash, urticaria and other constitutions; 6) had a severe infection, trauma, or major surgical procedure within 1 month before screening, had not recovered from surgery, or had planned surgery during the trial; 7) patients with a history of anesthesia accident, serious adverse reactions or family history of anesthesia accident; 8) patients with previous difficult ventilation or suspected difficult airway or expected difficult tracheal intubation (such as modified Mallampati score ?-?, congenital microglossia, mandibular dysplasia, etc.); 9) Patients with previous or current airway diseases such as asthma, chronic obstructive pulmonary disease, sleep apnea syndrome, bronchospasm requiring treatment within 3 months before screening, respiratory infection within 1 week before screening, or obvious symptoms such as fever, wheezing, nasal obstruction, and cough; 10) history of adrenal insufficiency or adrenal tumor or hereditary heme biosynthesis disorder or hereditary acute porphyria; 11) with a history of drug abuse, drug dependence, or drug abuse within 1 year before screening, or with positive urine drug screening results (morphine, methamphetamines, ketamine, THC, and methylenedioxymethamphetamine); 12) had a history of alcohol abuse within 6 months before screening (i.e., more than 14 standard units per week (1 unit =360 mL of beer or 45 mL of 40% spirits or 150 mL of wine) or had taken alcohol within 72 hours before screening or had a positive alcohol breath test (results > 0), or those who could not abstain from alcohol during the study period; 13) use of etomidate, propofol, other sedative/narcotic drugs and/or opioid analgesics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The success rate of diagnosis and treatment by gastroscopy and colonoscopy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Success rate of sedation/anesthesia;Time for BIS to reach 60 or below;Time for MOAA/S score =1;Duration from the end of consultation to full emergence;Time from the end of consultation to discharge from the room;Time from the end of care to hospital discharge;Blitt tremor classification score;Difference in area under the curve for cortisol between post-dose and baseline; | — |
Countries
China
Contacts
Public ContactWen Ouyang/ Saiying Wang
The Third Xiangya Hospital of Central South University
Outcome results
None listed